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FDA approves remdesivir, first treatment for COVID-19
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
making it the first and only approved treatment for COVID-19, according to a release from drug manufacturer Gilead Sciences.
The FDA’s initial Emergency Use Authorization (EUA) of the antiviral, issued in May, allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who needed oxygen therapy or mechanical ventilation.
An August EUA expanded treatment to include all adult and pediatric hospitalized COVID-19 patients, regardless of the severity of their disease. The FDA also issued a new EUA for remdesivir Oct. 22 allowing treatment of hospitalized pediatric patients younger than 12 weighing at least 3.5 kg.
Today’s approval is based on three randomized controlled trials, according to Gilead.
Final trial results from one of them, the National Institute of Allergy and Infectious Disease–funded ACTT-1 trial, published earlier in October, showed that hospitalized patients with COVID-19 who received remdesivir had a shorter median recovery time than those who received a placebo – 10 days versus 15 days.
This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was not a statistically significant difference in mortality between the treatment and placebo groups.
The other two trials used for the approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with a high prevalence of COVID-19 infections, according to Gilead.
The SIMPLE-Severe trial was a randomized, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing plus standard of care in 397 hospitalized adult patients with severe COVID-19. The primary endpoint was clinical status on day 14 assessed on a 7-point ordinal scale, according to Gilead.
The trial found that a 5-day or a 10-day treatment course of Veklury achieved similar clinical outcomes to the ACTT-1 trial (odds ratio, 0.75; 95% confidence interval, 0.51-1.12).
The SIMPLE-Moderate trial was a randomized, controlled, multicenter study that evaluated the efficacy and safety of 5-day and 10-day dosing durations of Veklury plus standard of care, compared with standard of care alone in 600 hospitalized adult patients with moderate COVID-19, Gilead stated in its release.
The primary endpoint was clinical status on day 11 assessed on a 7-point ordinal scale.
The results showed statistically improved clinical outcomes with a 5-day treatment course of Veklury, compared with standard of care (OR, 1.65; 95% CI, 1.0-2.48; P = .017), according to Gilead.
This article first appeared on Medscape.com.
Rinse and repeat? Mouthwash might mitigate COVID-19 spread
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Listerine Antiseptic led the list of most effective mouthwashes for inactivating the coronavirus. Interestingly, a 1% nasal rinse solution of Johnson’s Baby Shampoo also worked, eliminating up to 99.9% of the viral load in the in vitro experiments.
In contrast, use of a neti pot nasal solution yielded no decrease in virus levels.
The study was published in the Journal of Medical Virology.
Because the mouthwash and hydrogen peroxide oral rinses in the study are widely available and easy to use, “I would recommend the use of the rinses on top of wearing mask and social distancing. This could add a layer of protection for yourself and others,” lead study author Craig Meyers, PhD, professor of microbiology and immunology and obstetrics and gynecology, Penn State College of Medicine in Hershey, Pennsylvania, told Medscape Medical News.
Meyers and colleagues found that efficacy aligned with duration of time the cell cultures were exposed to each mouthwash or rinse product. Although it varied, the products required at least 30 seconds to kill most of the virus. Waiting 1 or 2 minutes tended to fortify results.
“This study adds to and further confirms the recently published evidence from virologists in Germany that mouthwashes can inactivate the virus that causes COVID-19 in a test tube,” Valerie O’Donnell, PhD, co-director of the Systems Immunity Research Institute of Cardiff University, Cardiff, Wales, said when asked to comment on the study.
“While this is great to see, what is still lacking is in vivo evidence, since we know the virus will be continually shed in the mouth,” O’Donnell said. “So, the question now becomes, by how much could mouthwashes reduce viral load in the oropharynx of infected people, and if so, then for how long?”
Meyers noted that studies of people positive for COVID-19 using each product would be informative. It remains unknown, for example, if swishing, gargling, and/or spitting out mouthwash would add or decrease the efficacy demonstrated in the lab.
The investigators used the human coronavirus HCoV‐229e as a surrogate for SARS-CoV-2. They noted HCoV-229e is analogous, and SARS-CoV-2 would have been more expensive, less available, and would have required biosafety level 3 laboratory conditions.
Listerine Antiseptic leads the way
“Surprisingly, we found that several of these common products had strong virucidal properties, inactivating from 2 log10 [or 99%] to greater than 4 log10 [or 99.99%] of infectious human coronavirus,” the researchers note.
The researchers added a small amount of organic material (extra protein) to each product to more closely mimic physiologic conditions in the nasopharynx.
Listerine Antiseptic “historically has claimed numerous antimicrobial properties,” the researchers note. Although the label currently only claims to kill germs that cause bad breath, “our tests show that it is highly effective at inactivating human coronavirus in solution. Even at the lowest contact time of 30 seconds, it inactivated greater than 99.99% of human coronavirus.”
Interestingly, the mouthwashes that contained the same active ingredients as Listerine Antiseptic — Listerine Ultra, Equate Antiseptic, and CVS Antiseptic Mouth Wash — were less efficacious. Meyers said the reason remains unclear, but he and colleagues found the same result when they repeated the comparisons.
Timing of the essence?
Meyers and colleagues also tested a nasal rinse solution of 1% baby shampoo because it is sometimes used to treat people with chronic rhinosinusitis. They found 30 seconds led to < 90% to < 99.99% effectiveness, but that, by 2 minutes, efficacy climbed to > 99.9% to > 99.99%.
“Thirty seconds for some products just was not enough time for the efficacy to be observed,” Meyers said. “Whereas, after a minute or two the active ingredient had enough time to work. Thirty seconds may be at the border to see full efficacy.” More research is needed to confirm the timing and determine which active ingredients are driving the findings.
A future trial could test the efficacy of mouthwash products to reduce the viral load in people with COVID-19. “If we are able to get funding to continue, I would like to see a small clinical trial as the next step,” Meyers said.
Meyers and O’Donnell disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Cardiogenic shock rate soars in COVID-positive ACS
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
COVID-19–positive patients undergoing an invasive strategy for acute coronary syndrome presented hours later than uninfected historical controls, had a far higher incidence of cardiogenic shock, and their in-hospital mortality rate was four- to fivefold greater, according to data from the Global Multicenter Prospective COVID–ACS Registry. These phenomena are probably interrelated, according to Anthony Gershlick, MBBS, who presented the registry results at the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
“We know that increasing ischemic time leads to bigger infarcts. And we know that bigger infarcts lead to cardiogenic shock, with its known higher mortality,” said Dr. Gershlick, professor of interventional cardiology at the University of Leicester (England).
“These data suggest that patients may have presented late, likely due to COVID concerns, and they had worse outcomes. If these data are borne out, future public information strategies need to be reassuring, proactive, simple, and more effective because we think patients stayed away,” the cardiologist added. “There are important public information messages to be taken from these data about getting patients to come to hospital during such pandemics.”
He presented prospectively collected registry data on 144 patients with confirmed ST-elevation MI (STEMI) and 122 with non-ST–elevation MI (NSTEMI), all COVID-19 positive on presentation at 85 hospitals in the United Kingdom, Europe, and North America during March through August of 2020. Since the initial message to the public early in the pandemic in many places was to try to avoid the hospital, the investigators selected for their no-COVID comparison group the data on more than 22,000 STEMI and NSTEMI patients included in two British national databases covering 2018-2019.
The COVID-positive STEMI patients were significantly younger, had more comorbidities, and had a higher mean heart rate and lower systolic blood pressure at admission than the non-COVID STEMI control group. Their median time from symptom onset to admission was 339 minutes, compared with 178 minutes in controls. Their door-to-balloon time averaged 83 minutes, versus 37 minutes in the era before the pandemic.
“I suspect that’s got something to do with the donning and doffing of personal protective equipment,” he said at the meeting sponsored by the Cardiovascular Research Foundation.
The in-hospital mortality rates were strikingly different: 27.1% in COVID-positive STEMI patients versus 5.7% in controls. Bleeding Academic Research Consortium type 3-5 bleeding was increased as well, by a margin of 2.8% to 0.3%. So was stroke, with a 2.1% in-hospital incidence in COVID-positive STEMI patients and a 0.1% rate in the comparator arm.
“But the biggest headline here for me was that the cardiogenic shock rate was 20.1% in the COVID-positive patients versus 8.7% in the non-COVID STEMI patients,” the cardiologist continued.
The same pattern held true among the COVID-positive NSTEMI patients: They were younger, sicker, and slower to present to the hospital than the non-COVID group. The in-hospital mortality rate was 6.6% in the COVID-positive NSTEMI patients, compared with 1.2% in the reference group. The COVID-positive patients had a 2.5% bleeding rate versus 0.1% in the controls. And the incidence of cardiogenic shock was 5%, compared with 1.4% in the controls from before the pandemic.
“Even though NSTEMI is traditionally regarded as lower risk, this is really quite dramatic. These are sick patients,” Dr. Gershlick observed.
Nearly two-thirds of in-hospital deaths in COVID-positive ACS patients were cardiovascular, and three-quarters of those cardiovascular deaths occurred in patients with cardiogenic shock. Thirty-two percent of deaths in COVID-positive ACS patients were of respiratory causes, and 4.9% were neurologic.
Notably, the ischemic time of patients with cardiogenic shock who died – that is, the time from symptom onset to balloon deployment – averaged 1,271 minutes, compared with 441 minutes in those who died without being in cardiogenic shock.
Session comoderator Sahil A. Parikh, MD, director of endovascular services at Columbia University Medical Center in New York, commented, “One of the striking things that is resonating with me is the high incidence of cardiogenic shock and the mortality. It’s akin to what we’ve seen in New York.”
Discussant Valentin Fuster, MD, PhD, said he doubts that the increased in-hospital mortality in the COVID–ACS registry is related to the prolonged time to presentation at the hospital. More likely, it’s related to the greater thrombotic burden various studies have shown accompanies COVID-positive ACS. It might even be caused by a direct effect of the virus on the myocardium, added Dr. Fuster, director of the Zena and Michael A. Wiener Cardiovascular Institute and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.
“I have to say I absolutely disagree,” responded Dr. Gershlick. “I think it’s important that we try to understand all the mechanisms, but we know that patients with COVID are anxious, and I think one of the messages from this registry is patients took longer to come to hospital, they were sicker, they had more cardiogenic shock, and they died. And I don’t think it’s anything more complicated than that.”
Another discussant, Mamas Mamas, MD, is involved with a 500-patient U.K. pandemic ACS registry nearing publication. The findings, he said, are similar to what Dr. Gershlick reported in terms of the high rate of presentation with cardiogenic shock and elevated in-hospital mortality. The COVID-positive ACS patients were also more likely to present with out-of-hospital cardiac arrest. But like Dr. Fuster, he is skeptical that their worse outcomes can be explained by a delay in seeking care.
“I don’t think the delay in presentation is really associated with the high mortality rate that we see. The delay in our U.K. registry is maybe half an hour for STEMIs and maybe 2-3 hours for NSTEMIs. And I don’t think that can produce a 30%-40% increase in mortality,” asserted Dr. Mamas, professor of cardiology at Keele University in Staffordshire, England.
Dr. Gershlick reported having no financial conflicts regarding his presentation.
FROM TCT 2020
Bronchoscopy can be conducted safely patients with severe COVID-19
Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.
Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.
“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”
Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”
For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.
Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.
The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.
The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.
The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.
About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.
“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”
Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.
“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”
The authors reported having no financial disclosures.
SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.
Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.
Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.
“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”
Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”
For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.
Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.
The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.
The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.
The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.
About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.
“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”
Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.
“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”
The authors reported having no financial disclosures.
SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.
Bronchoscopy with intermittent apnea can be conducted safely for both patients with severe COVID-19 and health care workers, a recent study has found. In addition, the high rate of superinfection in these patients indicates that bronchoalveolar lavage (BAL) should sent to the lab if there is any suspicion for secondary pneumonia.
Those are two key findings from a single-center retrospective study led by Stephanie H. Chang, MD, that was published in CHEST.
“While there is a risk of aerosolization and transmission of COVID-19 with bronchoscopy, this can be mitigated with bronchoscopy under intermittent apnea and appropriate PPE [personal protective equipment] in a negative-pressure room, with no significant adverse patient outcomes and a 0% rate of transmission to health care workers,” Dr. Chang, a thoracic surgeon in the department of cardiothoracic surgery at New York University Langone Health, said in an interview. “In appropriate clinical scenarios that will significantly impact patient care, bronchoscopy can be and should be safely performed in patients with COVID-19.”
Although a recent statement from the American Association for Bronchoscopy & Interventional Pulmonology indicates that bronchoscopy is relatively contraindicated in patients with suspected and confirmed COVID-19 infections, it does support use of the procedure in a subset of such patients. It reads: “The only role for bronchoscopy would be when less invasive testing to confirm COVID-19 are inconclusive, suspicion for an alternative diagnosis that would impact clinical management is suspected, or an urgent lifesaving intervention.”
For the current study, Dr. Chang and colleagues retrospectively studied the records of 412 patients with confirmed COVID-19 who were admitted to NYU Langone Health’s Manhattan campus between March 13 and April 24, 2020. If these, 321 required intubation and 107 (33%) underwent bronchoscopy, with a total of 241 bronchoscopies being performed.
Primary outcomes of interest were patient and health care provider safety, defined as freedom from periprocedural complications and COVID-19 transmission, respectively. Secondary outcomes included secondary infection with bacterial or fungal pneumonia.
The bronchoscopy team included six cardiothoracic surgeons and four cardiothoracic surgery residents. Each procedure was performed by a sole bronchoscopist in a negative-pressure room, with a bedside nurse immediately available outside of the room. The bronchoscopist wore full PPE, which consisted of hair cover, a fitted N95 mask, a face shield, gown, and gloves. Each patient was preoxygenated for 2 minutes with a fraction of inspired oxygen at 1.0 in order to maximize apneic time. For patients who were not on sedation and/or neuromuscular blockade, periprocedural anesthesia with propofol and rocuronium was employed to decrease the risk of spontaneous breathing leading to aerosolization.
The bronchoscope used in all cases was the disposable Ambu aScope and a corresponding monitor. The device was used to clear all secretions, clot, or mucus plugs, and to collect bronchoalveolar lavage (BAL) samples. If oxygen saturation decreased below 90%, the bronchoscopist interrupted the procedure and reconnected the patient to the ventilator. After an additional period of preoxygenation, bronchoscopy was then completed.
The mean age of the 107 patients was 62 years, and 81% were male. Dr. Chang and colleagues reported that, of the 241 bronchoscopies performed, no periprocedural complication of severe hypoxia requiring bag-valve ventilation, pneumothorax, or intraprocedural arrhythmias occurred, and that three patients required endotracheal tube advancement or replacement for dislodgement during the procedure.
About half of patients (51%) received a BAL, and 35 (65%) had a positive culture. Among 23 patients who had a negative tracheal culture, 8 patients had a positive BAL, which indicated a 35% diagnostic yield for patients with negative tracheal aspirates. In addition, three patients had differing cultures between the BAL and tracheal aspirate. One was growing Pseudomonas and Klebsiella in the tracheal aspirate with Enterococcus in the BAL, while the other two patients were growing an extra pathogen (Escherichia coli or Serratia) in the BAL.
“The most surprising data was the 65% rate of secondary infection with BAL, which is significantly higher than the rate in standard patients with acute respiratory distress syndrome,” Dr. Chang said. “Additionally, the high rate of bronchoscopy (33% in intubated patients) is also significantly higher than that of standard viral ARDS patients. This increased rate of superimposed infection and need for bronchoscopy may be due to the abnormally thick secretions seen in patients with COVID-19.”
Of the 10 cardiothoracic surgery team members, 1 resident was COVID-19 positive by reverse transcriptase polymerase chain reaction (rtPCR) prior to performing any bronchoscopies. The remaining nine team members tested negative for COVID-19 via nasal pharyngeal swab for rtPCR assay, with at least one negative test performed 2 weeks after the last bronchoscopy performed during the study period.
“The use of apnea was well tolerated by the patients and likely contributed to the lack of transmission of COVID-19 to the health care providers,” Dr. Chang said. “Additionally, this work demonstrates a higher rate of superinfection with bacterial or fungal pneumonia, compared to other reports. It is also the only one that describes the false negative rate for negative tracheal aspirates, which is the current recommended diagnostic test for secondary pneumonia in patients with COVID-19.” She acknowledged certain limitation of the study, including its retrospective design. “Thus, the clinical impact of bronchoscopy on patient outcomes cannot be accurately assessed.”
The authors reported having no financial disclosures.
SOURCE: Chang S et al. CHEST. 2020 Oct 8. doi: 10.1016/j.chest.2020.09.263.
FROM CHEST
Selexipag has no effect on daily activity in PAH patients
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Selexipag (Uptravi) does not change the level of daily activity of patients with pulmonary arterial hypertension (PAH), results from the phase 4 TRACE trial suggest.
“We had no preconceived idea if this drug would improve exercise capacity,” said Luke Howard, MD, of Imperial College Healthcare NHS Trust in London. It was clear, however, that 6-minute walk tests conducted a few times a year “don’t paint a picture of what daily life is like for patients on selexipag.”
The oral prostacyclin IP receptor agonist is prescribed to slow the progression of PAH and reduce hospital admissions, but there are no studies that show whether it improves quality of life.
Dr. Howard and his team turned to wearable technology to “capture a snapshot of everyday life,” he explained during his presentation at the annual meeting of the American College of Chest Physicians (CHEST 2020), held virtually this year.
The primary concern of the investigators was to get TRACE participants – all with PAH – to wear a wrist device; they did not encourage patients to become more active. “We wanted a true picture of the impact of the drug itself,” he noted.
After 24 months of daily tracking, “there was no benefit to increased daily activity for patients taking this drug,” Dr. Howard said in an interview. “That was a bit deflating.”
The daily activity of TRACE participants was “slightly more elevated” in the selexipag group than in the placebo group. “We saw some numerical drops in activity in the placebo group, and a trend that might make a difference over a longer, bigger study, but not in a statically significant way,” he reported.
In the randomized, blinded trial – the first to track the activity of PAH patients – 53 participants received selexipag and 55 received placebo. All 108 wore a wrist accelerometer (GT9X Link) that counted the number of steps taken each day, providing an indication of daily activity.
Device compliance – the mean number of days in which the device was worn for at least 7 hours during a 14-day predrug period – was similar in the selexipag and placebo groups (13.2 vs 13.0 days).
“We wanted to make sure we had people who were stable and weren’t enrolled in a rehabilitation program; we didn’t want any competing influences,” Dr. Howard explained. All in all, the participants were in pretty good shape. “There was a low risk of a bad outcome.”
The primary endpoint was change in activity from baseline to week 24. The secondary endpoints were PAH-SYMPACT health quality-of-life tests and 6-minute walk distance.
Similar activity levels in both groups
As expected in a population in which the majority of patients meet the criteria for WHO functional class II PAH, all participants had low PAH-SYMPACT domain scores throughout the trial.
All adverse events were “consistent with the known profile” of selexipag, and there were no deaths, Dr. Howard reported.
“We did not show any significant benefit to taking the drug,” he said, but the drug is marketed for the prevention of disease progression, and this finding “doesn’t change that.”
Pulmonary rehabilitation
“Pulmonary rehabilitation is one of the most vital management issues with chronic lung disease,” Riddhi Upadhyay, MD, of Carle Foundation Hospital in Urbana, Ill., said during her CHEST 2020 presentation on improving PAH rehabilitation referral rates.
“We know it improves exercise capacity, lung function, and decreases total hospital stays and recurrent hospital admission,” she explained. And studies have shown that PAH rehabilitation “also reduces frailty and improves quality of life.”
In their study, Dr. Upadhyay and colleagues showed that when pulmonary rehabilitation is added to the discharge order set, referrals increase by 60%.
They attribute their success to “recognizing the benefits of pulmonary rehab and understanding where interventions are required.”
An encouraging takeaway from the TRACE data is that it established that daily activity can be tracked in this patient population. “We think we might need to encourage these patients to get active, maybe combine the drug with a formal rehabilitation program; that might increase motivation,” Dr. Howard said.
“People don’t necessarily do more just because they can,” he noted.
Dr. Howard has received consulting fees from Actelion.
A version of this article originally appeared on Medscape.com.
Brazil confirms death of volunteer in COVID-19 vaccine trial
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
The Brazilian National Health Surveillance Agency (Anvisa) announced Oct. 21 that it is investigating data received on the death of a volunteer in a clinical trial of the COVID-19 vaccine developed by Oxford University and the pharmaceutical company AstraZeneca.
In an email sent to Medscape Medical News, the agency states that it was formally informed of the death on October 19. It has already received data regarding the investigation of the case, which is now being conducted by the Brazilian International Security Assessment Committee.
The identity of the volunteer and cause of death have not yet been confirmed by any official source linked to the study. In the email, Anvisa reiterated that “according to national and international regulations on good clinical practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants.”
A report in the Brazilian newspaper O Globo, however, states that the patient who died is a 28-year-old doctor, recently graduated, who worked on the front line of combating COVID-19 in three hospitals in Rio de Janeiro. . Due to the study design, it is impossible to know whether the volunteer received the vaccine or placebo.
It is imperative to wait for the results of the investigations, said Sergio Cimerman, MD, the scientific coordinator of the Brazilian Society of Infectious Diseases (SBI), because death is possible during any vaccine trial, even more so in cases in which the final goal is to immunize the population in record time.
“It is precisely the phase 3 study that assesses efficacy and safety so that the vaccine can be used for the entire population. We cannot let ourselves lose hope, and we must move forward, as safely as possible, in search of an ideal vaccine,” said Cimerman, who works at the Instituto de Infectologia Emílio Ribas and is also an advisor to the Portuguese edition of Medscape.
This article was translated and adapted from the Portuguese edition of Medscape.
COVID-19 experience forced residents to quickly improve patient communication skills
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
While the spring peak of COVID-19 was tough and traumatic for many residents and interns in a New York City health system, the experience may have accelerated their patient communication skills regarding difficult goals-of-care discussions, results of a recent survey suggest.
Breaking bad news was an everyday or every-other-day occurrence at the peak of the pandemic for nearly all of 50 of the trainees surveyed, who had worked at hospitals affiliated with the internal medicine residency program at the at the Icahn School of Medicine at Mount Sinai from March to June 2020.
However, trainees became significantly more comfortable and fluent in goals-of-care discussions during the pandemic, according to Patrick Tobin-Schnittger, MBBS, a third-year internal medicine resident in the Mount Sinai program.
“COVID-19 has obviously made a huge impact on the world, but I think it’s also made a huge impact on a whole generation of junior doctors,” said Dr. Tobin-Schnittger, who presented the findings in a late-breaking abstract session at the CHEST Annual Meeting, held virtually this year.
“It’ll be interesting to see what happens in the future as that generation matures, and I think one of the things is that we’re a lot more comfortable with end-of-life care,” he said in an interview conducted during the conference.
Nevertheless, coping with death may still be a challenge for many residents, according to Dr. Tobin-Schnittger. In the survey, internal medicine residents who had rarely encountered patient deaths suddenly found themselves experiencing deaths weekly, with more than one in five saying they were encountering it every day.
When asked to self-rate themselves according to Bugen’s Coping With Death scale, most participants had scores that suggested their ability to cope was suboptimal, the researcher said.
To help trainees cope with local COVID-19 surges, internal medicine residency programs should be implementing “breaking bad news” workshops and educating house staff on resilience in times of crisis, especially if it can be done virtually, according to Dr. Tobin-Schnittger.
“That could be done pretty quickly, and it could be done remotely so people could practice this from home,” he explained. “They wouldn’t even need to congregate in a big room.”
As a “mini-surge” of COVID-19 cases hits the United States, teaching self-care and coping techniques may also be important, said Mangala Narasimhan, DO, FCCP, director of critical care services at Northwell Health in New York City.
“We’ve had several sessions in our health system of letting people vent, talk about what happened, and tell stories about patients that they are still thinking about and haunted by – there was so much death,” Dr. Narasimhan said in an interview.
“People will be suffering for a long time thinking about what happened in March and April and May, so I think our focus now needs to be how to fix that in any way we can and to support people, as we’re dealing with these increases in numbers,” she said. “I think everyone’s panicking over the increase in numbers, but they’re panicking because of the fear of going through what they went through before.”
Dr. Tobin-Schnittger and colleagues sent their survey to 94 residents and interns in the Mount Sinai program who had worked through the peak of the pandemic. They received 50 responses. Of those individuals, the mean age was 29.5 years, and about 46% had worked for more than 3 years.
Before the pandemic, only 3 of the 50 respondents reported having goals-of-care conversations every day or every other day, while during the pandemic, those conversations were happening at least every other day for 38 of the respondents, survey data show.
Self-reported fluency and comfort with those discussions increased significantly, from a mean of about 50 on a scale of 100 before the pandemic to more than 75 during the pandemic, according to Dr. Tobin-Schnittger.
When asked how they remembered coping with patient death, one respondent described holding up a phone so a dying patient could hear his daughter’s voice. Another reported not being able to sleep at night.
“I constantly would have dreams that my patients were dying and there was nothing I could do about it,” the respondent said in a survey response.
A third respondent described the experience as ”humbling” but said there were rewarding aspects in patient care during the peak of the pandemic, which helped in being able to focus during difficult days.
Three participants (7.7%) said they changed their career plans as a result of the pandemic experience, the researchers reported.
Negative consequences of the peak pandemic experience included anger, anxiety, professional strain, trauma, and emotional distancing, some respondents reported.
However, others called attention to positive outcomes, such as more professional pride, resilience, confidence, and camaraderie.
“While we did encounter a lot of traumatic experiences, overall, there’s a huge sense that there is a lot more camaraderie within our department, but also within other departments,” said Dr. Tobin-Schnittger. “So I think there are some positives that come from this, and I think there’s been a bit of a culture change.”
Dr. Tobin-Schnittger said that he and his coauthors had no conflicts of interest or relationships with commercial interests to report.
SOURCE: Tobin-Schnittger P. CHEST 2020. Late-breaking abstract. doi: 10.1016/j.chest.2020.09.040.
FROM CHEST 2020
Outpatient visits rebound for most specialties to pre-COVID-19 levels
, according to new data.
Overall visits plunged by almost 60% at the low point in late March and did not start recovering until late June, when visits were still off by 10%. Visits began to rise again – by 2% over the March 1 baseline – around Labor Day.
As of Oct. 4, visits had returned to that March 1 baseline, which was slightly higher than in late February, according to data analyzed by Harvard University, the Commonwealth Fund, and the healthcare technology company Phreesia, which helps medical practices with patient registration, insurance verification, and payments, and has data on 50,000 providers in all 50 states.
The study was published online by the Commonwealth Fund.
In-person visits are still down 6% from the March 1 baseline. Telemedicine visits – which surged in mid-April to account for some 13%-14% of visits – have subsided to 6% of visits.
Many states reopened businesses and lifted travel restrictions in early September, benefiting medical practices in some areas. But clinicians in some regions are still facing rising COVID-19 cases, as well as “the challenges of keeping patients and clinicians safe while also maintaining revenue,” wrote the report authors.
Some specialties are still hard hit. For the week starting Oct. 4, visits to pulmonologists were off 20% from March 1. Otolaryngology visits were down 17%, and behavioral health visits were down 14%. Cardiology, allergy/immunology, neurology, gastroenterology, and endocrinology also saw drops of 5%-10% from March.
Patients were flocking to dermatologists, however. Visits were up 17% over baseline. Primary care also was popular, with a 13% increase over March 1.
At the height of the pandemic shutdown in late March, Medicare beneficiaries stayed away from doctors the most. Visits dipped 63%, compared with 56% for the commercially insured, and 52% for those on Medicaid. Now, Medicare visits are up 3% over baseline, while Medicaid visits are down 1% and commercially insured visits have risen 1% from March.
The over-65 age group did not have the steepest drop in visits when analyzed by age. Children aged 3-17 years saw the biggest decline at the height of the shutdown. Infants to 5-year-olds have still not returned to prepandemic visit levels. Those visits are off by 10%-18%. The 65-and-older group is up 4% from March.
Larger practices – with more than six clinicians – have seen the biggest rebound, after having had the largest dip in visits, from a decline of 53% in late March to a 14% rise over that baseline. Practices with fewer than five clinicians are still 6% down from the March baseline.
Wide variation in telemedicine use
The researchers reported a massive gap in the percentage of various specialties that are using telemedicine. At the top end are behavioral health specialists, where 41% of visits are by telemedicine.
The next-closest specialty is endocrinology, which has 14% of visits via telemedicine, on par with rheumatology, neurology, and gastroenterology. At the low end: ophthalmology, with zero virtual visits; otolaryngology (1%), orthopedics (1%), surgery (2%), and dermatology and ob.gyn., both at 3%.
Smaller practices – with fewer than five clinicians – never adopted telemedicine at the rate of the larger practices. During the mid-April peak, about 10% of the smaller practices were using telemedicine in adult primary care practices, compared with 19% of those primary care practices with more than six clinicians.
The gap persists. Currently, 9% of the larger practices are using telemedicine, compared with 4% of small practices.
One-third of all provider organizations analyzed never-adopted telemedicine. And while use continues, it is now mostly minimal. At the April peak, 35% of the practices with telemedicine reported heavy use – that is, in more than 20% of visits. In September, 9% said they had such heavy use.
A version of this article originally appeared on Medscape.com.
, according to new data.
Overall visits plunged by almost 60% at the low point in late March and did not start recovering until late June, when visits were still off by 10%. Visits began to rise again – by 2% over the March 1 baseline – around Labor Day.
As of Oct. 4, visits had returned to that March 1 baseline, which was slightly higher than in late February, according to data analyzed by Harvard University, the Commonwealth Fund, and the healthcare technology company Phreesia, which helps medical practices with patient registration, insurance verification, and payments, and has data on 50,000 providers in all 50 states.
The study was published online by the Commonwealth Fund.
In-person visits are still down 6% from the March 1 baseline. Telemedicine visits – which surged in mid-April to account for some 13%-14% of visits – have subsided to 6% of visits.
Many states reopened businesses and lifted travel restrictions in early September, benefiting medical practices in some areas. But clinicians in some regions are still facing rising COVID-19 cases, as well as “the challenges of keeping patients and clinicians safe while also maintaining revenue,” wrote the report authors.
Some specialties are still hard hit. For the week starting Oct. 4, visits to pulmonologists were off 20% from March 1. Otolaryngology visits were down 17%, and behavioral health visits were down 14%. Cardiology, allergy/immunology, neurology, gastroenterology, and endocrinology also saw drops of 5%-10% from March.
Patients were flocking to dermatologists, however. Visits were up 17% over baseline. Primary care also was popular, with a 13% increase over March 1.
At the height of the pandemic shutdown in late March, Medicare beneficiaries stayed away from doctors the most. Visits dipped 63%, compared with 56% for the commercially insured, and 52% for those on Medicaid. Now, Medicare visits are up 3% over baseline, while Medicaid visits are down 1% and commercially insured visits have risen 1% from March.
The over-65 age group did not have the steepest drop in visits when analyzed by age. Children aged 3-17 years saw the biggest decline at the height of the shutdown. Infants to 5-year-olds have still not returned to prepandemic visit levels. Those visits are off by 10%-18%. The 65-and-older group is up 4% from March.
Larger practices – with more than six clinicians – have seen the biggest rebound, after having had the largest dip in visits, from a decline of 53% in late March to a 14% rise over that baseline. Practices with fewer than five clinicians are still 6% down from the March baseline.
Wide variation in telemedicine use
The researchers reported a massive gap in the percentage of various specialties that are using telemedicine. At the top end are behavioral health specialists, where 41% of visits are by telemedicine.
The next-closest specialty is endocrinology, which has 14% of visits via telemedicine, on par with rheumatology, neurology, and gastroenterology. At the low end: ophthalmology, with zero virtual visits; otolaryngology (1%), orthopedics (1%), surgery (2%), and dermatology and ob.gyn., both at 3%.
Smaller practices – with fewer than five clinicians – never adopted telemedicine at the rate of the larger practices. During the mid-April peak, about 10% of the smaller practices were using telemedicine in adult primary care practices, compared with 19% of those primary care practices with more than six clinicians.
The gap persists. Currently, 9% of the larger practices are using telemedicine, compared with 4% of small practices.
One-third of all provider organizations analyzed never-adopted telemedicine. And while use continues, it is now mostly minimal. At the April peak, 35% of the practices with telemedicine reported heavy use – that is, in more than 20% of visits. In September, 9% said they had such heavy use.
A version of this article originally appeared on Medscape.com.
, according to new data.
Overall visits plunged by almost 60% at the low point in late March and did not start recovering until late June, when visits were still off by 10%. Visits began to rise again – by 2% over the March 1 baseline – around Labor Day.
As of Oct. 4, visits had returned to that March 1 baseline, which was slightly higher than in late February, according to data analyzed by Harvard University, the Commonwealth Fund, and the healthcare technology company Phreesia, which helps medical practices with patient registration, insurance verification, and payments, and has data on 50,000 providers in all 50 states.
The study was published online by the Commonwealth Fund.
In-person visits are still down 6% from the March 1 baseline. Telemedicine visits – which surged in mid-April to account for some 13%-14% of visits – have subsided to 6% of visits.
Many states reopened businesses and lifted travel restrictions in early September, benefiting medical practices in some areas. But clinicians in some regions are still facing rising COVID-19 cases, as well as “the challenges of keeping patients and clinicians safe while also maintaining revenue,” wrote the report authors.
Some specialties are still hard hit. For the week starting Oct. 4, visits to pulmonologists were off 20% from March 1. Otolaryngology visits were down 17%, and behavioral health visits were down 14%. Cardiology, allergy/immunology, neurology, gastroenterology, and endocrinology also saw drops of 5%-10% from March.
Patients were flocking to dermatologists, however. Visits were up 17% over baseline. Primary care also was popular, with a 13% increase over March 1.
At the height of the pandemic shutdown in late March, Medicare beneficiaries stayed away from doctors the most. Visits dipped 63%, compared with 56% for the commercially insured, and 52% for those on Medicaid. Now, Medicare visits are up 3% over baseline, while Medicaid visits are down 1% and commercially insured visits have risen 1% from March.
The over-65 age group did not have the steepest drop in visits when analyzed by age. Children aged 3-17 years saw the biggest decline at the height of the shutdown. Infants to 5-year-olds have still not returned to prepandemic visit levels. Those visits are off by 10%-18%. The 65-and-older group is up 4% from March.
Larger practices – with more than six clinicians – have seen the biggest rebound, after having had the largest dip in visits, from a decline of 53% in late March to a 14% rise over that baseline. Practices with fewer than five clinicians are still 6% down from the March baseline.
Wide variation in telemedicine use
The researchers reported a massive gap in the percentage of various specialties that are using telemedicine. At the top end are behavioral health specialists, where 41% of visits are by telemedicine.
The next-closest specialty is endocrinology, which has 14% of visits via telemedicine, on par with rheumatology, neurology, and gastroenterology. At the low end: ophthalmology, with zero virtual visits; otolaryngology (1%), orthopedics (1%), surgery (2%), and dermatology and ob.gyn., both at 3%.
Smaller practices – with fewer than five clinicians – never adopted telemedicine at the rate of the larger practices. During the mid-April peak, about 10% of the smaller practices were using telemedicine in adult primary care practices, compared with 19% of those primary care practices with more than six clinicians.
The gap persists. Currently, 9% of the larger practices are using telemedicine, compared with 4% of small practices.
One-third of all provider organizations analyzed never-adopted telemedicine. And while use continues, it is now mostly minimal. At the April peak, 35% of the practices with telemedicine reported heavy use – that is, in more than 20% of visits. In September, 9% said they had such heavy use.
A version of this article originally appeared on Medscape.com.
Teen vaping in the time of COVID-19
It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.
“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.
Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.
“In 2020, approximately 1 in 5 high school students and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.
“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.
“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
Flavor of the moment
Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.
Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.
On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”
But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.
Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?
“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”
There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.
The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.
“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
E-cigarettes and COVID-19
A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .
Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.
“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”
Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”
He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
An ounce of prevention
“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.
Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.
Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”
Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.
It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.
“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.
Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.
“In 2020, approximately 1 in 5 high school students and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.
“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.
“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
Flavor of the moment
Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.
Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.
On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”
But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.
Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?
“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”
There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.
The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.
“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
E-cigarettes and COVID-19
A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .
Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.
“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”
Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”
He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
An ounce of prevention
“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.
Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.
Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”
Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.
It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.
“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.
Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.
“In 2020, approximately 1 in 5 high school students and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.
“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.
“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
Flavor of the moment
Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.
Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.
On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”
But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.
Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?
“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”
There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.
The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.
“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
E-cigarettes and COVID-19
A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .
Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.
“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”
Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”
He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
An ounce of prevention
“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.
Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.
Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”
Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.
Survey: Acceptance of COVID-19 vaccine dips below 50%
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.
Less than half of Americans now say that they would get a coronavirus vaccine if one became available, according to a survey conducted Oct. 8-10.
the lowest number since the weekly survey began at the end of February, digital media company Morning Consult reported.
Americans’ willingness to receive such a vaccine reached its high point, 72%, in early April but has been steadily dropping. “Overall willingness has hovered around 50% throughout September, fueled primarily by a sharp drop among Democrats since mid-August, around the time reports of White House interference at the Food and Drug Administration and other federal health agencies began to command more public attention,” Morning Consult noted.
Despite that drop, a majority of Democrats (55%) are still willing to get a COVID-19 vaccine, compared with 48% of Republicans and just 41% of independents. The willingness gap between the two parties was quite a bit wider in the previous poll, conducted Oct. 1-4: 60% of Democrats versus 48% for Republicans, the company said.
“Keeping with longstanding trends, the survey also shows women were less likely to say they’d seek a vaccine than men (42% to 55%), as were people with lower education levels and those who live in rural areas,” the news outlet added.
The latest poll results also show that 33% of respondents (43% of Republicans/25% of Democrats) are socializing in public places. The overall number was just 8% in mid-April but was up to 27% by mid-June. The proportion of all adults who believe in the effectiveness of face masks has been around 80% since April, but there is a significant gap between those who strongly approve of President Trump (66%) and those who strongly disapprove (95%), Morning Consult said.